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Density

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Reference
Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted on 18 March 2010.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.3 (Relative Density)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
(Date of GLP inspection: 2009-09-15 Date of Signature on GLP certificate: 2009-11-26)
Type of method:
air comparison pycnometer (for solids)
Type:
relative density
Density:
2.72
Temp.:
21.5 °C

Results

Calibration

The pressure readings (P1and P2) and the calculated volume for the calibration ball are shown in the following table:

Determination

P1

P2

Volume (cm3)

Certified Volume (cm3)

Tolerance

(cm3)

A

17.457

6.827

1.052

1.073

± 0.05

B

17.210

6.734

1.062

1.073

± 0.05

C

17.250

6.749

1.061

1.073

± 0.05

D

17.258

6.753

1.063

1.073

± 0.05

Sample

The pressure readings, calculated volumes and density values obtained for the test item are shown in the following table:

Determination

P1

P2

Volume (cm3)

Density

(kg/m3)

A

17.380

6.726

0.851

2711.4

B

17.589

6.806

0.849

2730.8

Temperature:            21.5 ± 0.5ºC
Mean density:                       2721.1 kg/m3
Relative density:                   2.72

Conclusions:
The relative density of the test item has been determined to be 2.72 at 21.5 ± 0.5°C.
This study is conducted according to an appropriate guideline and under the conditions of GLP and therefore the study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint.
Executive summary:

The relative density of the test material has been determined to be 2.72 at 21.5 ± 0.5°C, using a gas comparison pycnometer, designed to be compatible with Method A3 Relative Density of Commission Regulation (EC) No 440/2008 of 30 May 2008.

Description of key information

One key study exists. This study (Wooley A, 2010) was conclusive, done to a valid guideline (EU Method A.3) and the study was conducted under GLP conditions.

Key value for chemical safety assessment

Additional information

The relative density of the test item has been determined to be 2.72 at 21.5 ± 0.5°C.